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Health Highlights: Nov. 15, 2018
Posted today in Medical
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Newer Nonstick Coating May Pose Health Threat: EPA A chemical compound used to make newer nonstick coatings could be dangerous, according to draft findings from the U.S. Environmental Protection Agency. It said that animal studies show the so-called GenX nonstick compound could affect the kidneys, blood, immune... Read more
The Jobs That Carry the Highest Suicide Risk
Posted today in Medical
THURSDAY, Nov. 15, 2018 -- The rate of suicide among U.S. workers has jumped 34 percent since 2000, and certain occupations seem to be riskier than others, government health researchers report. Those most at risk: men with construction and extraction jobs, and women in arts, design, entertainment, sports and media, according to the U.S. Centers for Disease Control and Prevention. "Increasing suicide rates in the... Read more
AHA: Caring for Loved One With Heart Failure Even Tougher for Rural Americans
Posted today in Medical
THURSDAY, Nov. 15, 2018 (American Heart Association) -- Living in a rural area increases the difficulty of caring for someone with heart failure, according to new research. An estimated 6.5 million U.S. adults ages 20 and older have heart failure, a serious condition that develops when the heart can't pump enough blood and oxygen to support other organs in the body. People with heart failure often experience... Read more
FDA Moves to Restrict Flavored E-Cig Sales, Ban Menthol Cigarettes
Posted today in Medical
THURSDAY, Nov. 15, 2018 -- The U.S. Food and Drug Administration said Thursday it will take steps to limit or ban access to flavored e-cigarettes, menthol cigarettes and flavored cigars. The move against flavored e-cigarettes stops short of the full ban that had been expected from the agency. Instead, sales of these products -- thought to be especially alluring to teens -- will only be allowed in stores within... Read more
Climate Change Could Change the Ragweed Sneezin' Season
Posted today in Medical
THURSDAY, Nov. 15, 2018 -- If you live in Maine and you've never experienced hay fever, new research predicts that climate change has an unwelcome surprise in store for you. Warmer temperatures in the northern United States will allow ragweed -- the plant that triggers hay fever -- to flourish in areas it's never been before. About 35 years from now, the study predicts, ragweed will be found in New Hampshire,... Read more
CDC: Many Americans May Have Prediabetes and Not Know It
Posted today in News for Health Professionals
THURSDAY, Nov. 15, 2018 -- More than one-third of Americans have prediabetes, but 90 percent of them do not know they have it, medical experts say. Nov. 14 was World Diabetes Day, and the American Medical Association and U.S. Centers for Disease Control and Prevention launched a campaign to raise awareness about prediabetes and encourage people to find out if they have the condition. "Prediabetes can often be... Read more
Option Found for Retreatment of Chronic Hep C Infection
Posted today in News for Health Professionals
THURSDAY, Nov. 15, 2018 -- Combined treatment with glecaprevir and pibrentasvir (G/P) is highly effective in treating chronic hepatitis C virus (HCV) genotype-1 infections that failed to respond to direct-acting antiviral therapy, according to a study presented at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases, held from Nov. 9 to 13 in San Francisco. Mark S.... Read more
Many Patients Do Not Engage Health Care Provider During MS Relapse
Posted today in News for Health Professionals
THURSDAY, Nov. 15, 2018 -- The rate and frequency of relapse vary for patients with multiple sclerosis (MS), and many report not visiting a health care provider during relapse, according to a study published in the November issue of Multiple Sclerosis and Related Disorders. Tara A. Nazareth, from Mallinckrodt Pharmaceuticals in Bedminster, New Jersey, and colleagues used data from the Multiple Sclerosis in America... Read more
Mental Health Conditions, Suicide Up After Major Trauma
Posted today in News for Health Professionals
THURSDAY, Nov. 15, 2018 -- Survivors of major trauma have an elevated risk for mental health conditions or death by suicide in the five years after injury, according to a study published in the Nov. 12 issue of CMAJ, the journal of the Canadian Medical Association. Christopher C.D. Evans, M.D., from Queen's University in Kingston, Canada, and colleagues completed a population-based self-controlled longitudinal study... Read more
Breast Cancer Recurrence Rate Not Up With Autologous Fat Transfer
Posted today in News for Health Professionals
THURSDAY, Nov. 15, 2018 -- For patients with breast cancer, reconstruction with autologous fat transfer (AFT) seems not to increase the rate of locoregional recurrence versus conventional breast reconstruction, according to a study published online Oct. 10 in JAMA Surgery. Todor Krastev, M.D., Ph.D., from the Maastricht University Medical Center in the Netherlands, and colleagues matched 287 patients with 300... Read more
Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine
Posted yesterday in New Drug Applications
INDIANAPOLIS, Nov. 14, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute treatment of migraine with or without aura in adults. Lasmiditan is an investigational, oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally and mechanistically distinct... Read more
FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD)
Posted 6 days ago in New Drug Approvals
DUBLIN, Ireland, HERTFORDSHIRE, England and PITTSBURGH, Nov. 9, 2018 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ: MYL) ("Mylan") today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Yupelri (revefenacin) inhalation solution for the maintenance treatment of patients with... Read more
FDA Approves Newly Formulated OTC Primatene Mist (epinephrine) to Treat Mild Asthma
Posted 8 days ago in New Drug Approvals
RANCHO CUCAMONGA, Calif., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced today that the U.S. Food and Drug Administration (FDA) granted approval of its New Drug Application (NDA) for Primatene Mist (epinephrine inhalation aerosol bronchodilator suspension), which is delivered by a metered dose inhaler (MDI) with a non-chlorofluorocarbon (CFC) propellant. Primatene Mist is... Read more
Bausch Health Announces U.S. Launch of Bryhali (halobetasol propionate) Lotion, 0.01%, for Plaque Psoriasis In Adults
Posted 8 days ago in New Drug Approvals
LAVAL, Quebec, Nov. 7, 2018 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced it expects to start distribution of Bryhali (halobetsasol propionate) Lotion, 0.01%, to U.S. wholesale pharmaceutical distributors later this month. The company received final approval from the... Read more
FDA Approves Empliciti (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma
Posted 9 days ago in New Drug Approvals
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.1 In... Read more
FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta
Posted 12 days ago in New Drug Approvals
REDWOOD CITY, Calif., Nov. 02, 2018 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced that the U.S. Food and Drug Administration (FDA) has approved Udenyca (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy. Udenyca is Coherus’ first drug to receive FDA or EC a... Read more
Trevena Receives Complete Response Letter for Oliceridine from FDA
Posted 13 days ago in New Drug Applications
November 2, 2018 -- Trevena, Inc. (NASDAQ: TRVN) today announced the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for oliceridine. “While we are disappointed with FDA’s decision, we continue to believe in the strength of the data and the ultimate approvability of oliceridine,” said Carrie L. Bourdow,... Read more
Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of Zulresso (brexanolone) Injection for Treatment of Postpartum Depression
Posted 13 days ago in New Drug Applications
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 2, 2018-- Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) jointly voted (17 yes,... Read more
Alkermes Reports on Outcome of FDA Advisory Committee Meeting on ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder
Posted 2 weeks ago in New Drug Applications
DUBLIN, Nov. 1, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA), met to review the company's New Drug Application (NDA) for ALKS 5461. The committee jointly voted that the benefit-risk profile was not adequate to support... Read more
Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management
Posted 2 weeks ago in New Drug Applications
SAN DIEGO, Oct. 31, 2018 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011. HTX-011 is an investigational,... Read more
Attenua Announces First Patient Treated in Phase 2 Clinical Trial in Chronic Cough with Bradanicline
Posted today in Clinical Trials
San Mateo, Calif, Nov 14, 2018 – Attenua, Inc., a clinical-stage biopharmaceutical company focused on developing novel medicines to treat cough, today announced that the first patient has been treated in a Phase 2 clinical trial in chronic cough with bradanicline (formerly known as ATA-101), its lead compound. “Within just six months of our initial Series A funding, Attenua has successfully filed an... Read more
Entasis Therapeutics Announces Zoliflodacin Phase 2 Results Published in The New England Journal of Medicine
Posted 7 days ago in Clinical Trials
WALTHAM, Mass., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Entasis Therapeutics (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, announced that The New England journal of Medicine (NEJM) published results from a Phase 2 clinical trial evaluating the safety and efficacy of zoliflodacin in patients with uncomplicated gonorrhea. Zoliflodacin... Read more
Janssen Reports Positive Topline Results for FLAIR Phase 3 Study of a Novel, Long Acting Injectable Two-Drug Regimen for the treatment of HIV-1
Posted 2 weeks ago in Clinical Trials
CORK, IRELAND, October 31, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson today confirmed positive topline results from the global, Phase 3 FLAIR (First Long-Acting Injectable Regimen) study of a long-acting, injectable two-drug regimen (2DR) for the treatment of HIV. The study, conducted by ViiV Healthcare, showed long-acting rilpivirine and cabotegravir, injected once a month, had... Read more
Two-year data for Novartis brolucizumab reaffirm superiority versus aflibercept in reducing retinal fluid in patients with nAMD
Posted 2 weeks ago in Clinical Trials
Basel, 27 October, 2018 - Novartis announced additional brolucizumab Phase III results from year two that reaffirmed its positive year one findings. Brolucizumab met its primary endpoint of non-inferiority versus aflibercept in best corrected visual acuity (BCVA) and exhibited superiority in key retinal outcomes at year one (48 weeks)[1],[2]. Secondary endpoints at year two (96 weeks) reaffirmed superiority of... Read more
New STAIRWAY Study Data Shows Potential for Extended Durability With Faricimab in Wet Age-Related Macular Degeneration (AMD)
Posted 2 weeks ago in Clinical Trials
South San Francisco, CA -- October 27, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase II STAIRWAY study which explored the extended durability of faricimab (RG7716) in the treatment of wet age-related macular degeneration (AMD), a leading cause of blindness in people aged 60 and over in the United States.3 At 52 weeks, faricimab patients... Read more
